New diabetes guidelines ease systolic blood pressure target

Miriam E Tucker

December 27, 2012

Alexandria, VA - New clinical-practice guidelines from the American Diabetes Association (ADA) include recommendations for a less stringent systolic blood-pressure target and greater individualization with regard to the frequency of blood glucose self-monitoring[1].

The ADA's Clinical Practice Recommendations 2013 are published as a supplement to the January 2013 issue of Diabetes Care. Revised on an annual basis, the document includes the association's major position statement along with additional position statements on a range of diabetes-management-related topics.

This year, the revisions reflect the increasing use of evidence-based recommendations in addition to the recognition that the population-based evidence derived from studies needs to be tailored to the individual patient, said Dr Richard Grant (Kaiser Permanente Division of Research, Oakland, CA), incoming chair of the ADA Professional Practice Committee.

"The changes reflect a broader trend in ADA standards and also how we take care of patients with type 2 diabetes," said Grant.

Blood pressure

The new ADA guidelines raise the target for systolic blood pressure from <130 mm Hg to <140 mm Hg based on evidence that there is not a great deal of additional value in aiming for the lower target, but there is an increase in risk in pushing systolic pressure lower than 140 mm Hg, Grant explained.

The primary data for that recommendation came from a meta-analysis that demonstrated that although the use of intensive vs standard blood-pressure targets in patients with type 2 diabetes was associated with a small reduction in the risk for stroke, there was no evidence for decreased mortality or MI, but an increased risk for hypotension and other adverse events.

The previous target of <130 mm Hg had not been derived from randomized, controlled trials, but from observational studies that seemed to suggest lower is better for blood pressure in those with diabetes, Grant explained.

However, the new ADA recommendations do say that a target <130 mm Hg might be appropriate for certain individuals, such as younger patients, as long as it can be achieved "without undue treatment burden."

Grant stressed that raising the systolic threshold should not be interpreted to mean that blood-pressure control is not important.

"We really tried to communicate that it's crucially important that everyone with type 2 diabetes have a [systolic] blood pressure down to 140 [mm Hg]," he said. "It's a very important threshold. Changing the recommendation is not meant to imply that excellent blood-pressure control is not as much of a priority as it was." However, Dr Yehuda Handelsman (Metabolic Institute of America, Tarzana, CA) said he is concerned about just that. "I believe the headline sends the wrong message. This will be interpreted that's its less important to get to a more intensive goal."

There have been no new prospective data in the past year to merit the change, said Handelsman, immediate past president and chair of the Diabetes Scientific Committee of the American Association of Clinical Endocrinologists (AACE).

"There are no new studies, only meta-analyses, which are for generating hypotheses that need to be tested," said Handelsman.

Regarding adverse events, Handelsman pointed out that in the Action to Control Cardiovascular Risk in Diabetes [ACCORD] trial, the average blood pressure achieved in the standard group, which had a target of <140 mm Hg, was 133.5 mm Hg compared with 119.3 mm Hg in the intensive treatment group, which had a target blood pressure of <120 mm Hg.

In ACCORD, the annual stroke rates were 0.32% vs 0.53% in the intensive and standard BP-control groups, respectively (hazard ratio [HR] 0.59, 95% CI 0.39-0.89, p=0.01), whereas adverse events such as syncope and dizziness occurred in 1.3% vs 3.3% in the intensive and standard groups, respectively.

"Based on this trial, to say that a systolic blood pressure of 130 [mmHg] is dangerous is wrong," said Handelsman.

He added that he believes that what the ADA should have advised (and did, in fact, do so, but only secondarily) is that "if you can get to <130 [mm Hg] and do it safely, you should do it."

Handelsman noted that he was voicing his own views and not those of the AACE.

Blood glucose self-monitoring

The new ADA blood glucose self-monitoring recommendations do not prescribe how many tests should be done but rather focus on the individual situations in which testing should occur.

For patients with type 1 or type 2 diabetes who take multiple daily doses of insulin or are on pump therapy, the previous recommendation had been that these patients perform blood glucose self-monitoring "three or more times daily." Some payers had interpreted that to mean that three tests a day was sufficient for all patients, Grant noted.

The 2013 ADA advice for patients on intensive insulin therapy is for testing at least before meals, occasionally after eating, at bedtime, before exercise or critical tasks such as driving, when low blood glucose is suspected, and after treating low blood glucose to ensure normoglycemia has been reached.

"We're trying to say it's very situation-dependent . . . both by the patient and the patient's context," he said.

In contrast, for patients with type 2 diabetes who take basal insulin or noninsulin diabetes treatments, blood glucose self-monitoring is still recommended as being potentially helpful to guide treatment decisions "when prescribed as part of a broader educational context," but only when patients are educated about how to use of the results.

In general, Grant said, for patients not taking insulin, blood glucose self-monitoring "is really not any use if it's not being acted on. . . . If no one looks at the results, there's no sense testing."

With regard to the removal of the three-times-daily number, Handelsman expressed concern that insurers might actually interpret that as endorsing less frequent testing for patients who use insulin.

How messages are conveyed matters, he said. "It's about how you define the goals and where you put the emphasis."

However, Handelsman did endorse other revisions, including a new recommendation for hepatitis B vaccination in people with diabetes.

According to Grant, the new document was the ADA's best attempt to balance the evidence from the literature with the needs of the individual patient. "Evidence-based guidelines apply to populations of patients with diabetes, but we really need to tailor these population-level recommendations to the individual in front of us."

Grant disclosed no relevant financial relationships. Handelsman disclosed receiving research grants from Boehringer Ingelheim, ConjuChem, Daiichi Sankyo, GlaxoSmithKline, Lexicon, Merck, Novo Nordisk, S anofi, Takeda, Tolerx, and Xoma. He serves as a consultant for Amarin, Amylin, Daiichi Sankyo, Gilead, Halozyme, LipoScience, Merck, Novo Nordisk, S anofi, ResMed, Santarus, Titus, and Vivus and is on the speaker's bureau for Amylin, AstraZeneca, Boehringer Ingelheim, B ristol- M yers S quibb , Daiichi Sankyo, GlaxoSmithKline, Lilly, Novo No rdisk, Santarus, and Vivus.

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